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Publicaties

Evaluation of an individual feedback report on patient‑reported outcomes in the Prospective Dutch ColoRectal Cancer cohort

31 mei 2022

Purpose

Returning patient-reported outcomes to patients might aid patients in detecting symptoms and might facilitate early intervention. This descriptive study evaluates the use of an individual feedback report on patient-reported outcomes for colorectal cancer patients and aims to assess differences in patient, tumor, and treatment characteristics and cohort retention between patients who opt and do not opt for the feedback report.

 

Methods

Patients with colorectal cancer participating in the nationwide Prospective Dutch ColoRectal Cancer Cohort, who filled in questionnaires digitally between June 2018 and January 2019, were included. Participants were given the option to receive a feedback report at baseline, 3, 6, and 12 months. The usefulness, content, and layout of the feedback report were evaluated. Differences in patient, tumor, and treatment characteristics, patientreported outcomes, and cohort retention at subsequent questionnaires between participants who did and did not opt for feedback were assessed.


Results

A total of 484 participants were included of whom 293 (61%) opted for feedback. The feedback report was considered useful by 92%. No differences in patient, tumor, and treatment characteristics, and patient-reported outcomes were found between participants who did and did not opt for feedback. The response rate was higher among patients who opted for feedback compared to patients who did not opt for feedback at T3 (84 vs 74%), but not at T6 and T12.


Conclusion

The feedback report was used by 6 out of 10 patients. The feedback report was considered valuable and associated with a higher subsequent response rate.

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Quality of life and survival of metastatic colorectal cancer patients treated with trifluridine-tipiracil (QUALITAS)

24 maart 2022

Introduction

The RECOURSE trial demonstrated a modest benefit in overall survival (OS) for trifluridine/tipiracil (FTD/TPI) versus placebo in pretreated metastatic colorectal cancer (mCRC) patients. Unfortunately, quality of life (QoL) was not assessed. We evaluated QoL and survival of patients treated with FTD/TPI in daily practice.
 

Methods

QUALITAS is a substudy of the Prospective Dutch CRC cohort (PLCRC). From 150 mCRC patients treated with FTD/TPI, QoL (EORTC QLQ-C30 and QLQ-CR29) was assessed monthly from study entry and linked to clinical data of the Netherlands Cancer Registry. Joint models were constructed combining mixed effects models with Cox PH models. Primary endpoint was difference in QoL over time (which was deemed clinically relevant if ≥10 points). Secondary endpoints were progression-free survival (PFS), time to treatment failure (TTF), and OS. We analyzed the association between QLQ-C30 Summary Score (QoL-SS) at FTD/TPI initiation (baseline) and survival.
 

Results

There was no clinically relevant change in QoL-SS from baseline to 10 months post-baseline (i.e. the cut-off point after which 90% of patients had discontinued FTD/TPI treatment): -5.3 [95% CI -8.7;-1.5]. Patients who were treated with FTD/TPI for ≥3 months (n=85) reported 6.3 [1.6;11.1] points higher baseline QoL, compared to patients treated <3 months (n=65, ‘poor responders’). In the latter, time to a clinically relevant QoL deterioration was <2 months. Median PFS, TTF and OS were 2.9 [2.7;3.1], 3.1 [2.9;3.2] and 7.7 [6.6;8.8] months, respectively. Worse baseline QoL-SS was independently associated with shorter OS (HR 0.45 [0.32;0.63]), PFS (0.63 [0.48;0.83]), and TTF (0.64 [0.47;0.86]).
 

Conclusions

The maintenance of QoL during FTD/TPI treatment in daily practice supports its use. The QoL deterioration in ‘poor responders’ is likely due to disease progression. The strong association between worse baseline QoL and shorter survival suggests that clinicians should take QoL into account when determining prognosis and treatment strategy for individual patients.

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Long-Term Safety Data on S-1 Administered After Previous Intolerance to Capecitabine-Containing Systemic Treatment for Metastatic Colorectal Cancer

2 maart 2022

Introduction

The oral fluoropyrimidine S-1 has shown comparable efficacy to capecitabine in Asian and some Western studies on metastatic colorectal cancer. S-1 is associated with a lower incidence of hand-foot syndrome (HFS) and cardiac toxicity. We assessed the long-term tolerability of S-1 in patients who discontinued capecitabine for reasons of HFS or cardiac toxicity.

 

Patients and Methods

Patients with metastatic colorectal cancer who switched from capecitabine to S-1, given as monotherapy or in combination with other agents, were identified in a Dutch prospective cohort study (2016-2021). The incidence and severity of HFS, cardiotoxicity and other toxicities were assessed.

 

Results

Forty-seven patients were identified. The median duration of capecitabine treatment was 81 days (range 4-454). In 19 patients (40%) a dose reduction was applied prior to switch to S-1. Reasons for discontinuation of capecitabine were HFS in 36 (77%) patients, coronary artery vasospasms in 10 (21%) patients, and gastrointestinal toxicities in 1 patient (2%). The median number of S-1 cycles was 6 (range 1-36). The median time between last dose of capecitabine and first dose of S-1 was 11 days (range 1-49). After switch to S-1, all patients with prior HFS developed a lower grade or complete resolution of symptoms, and in all other patients symptoms did not recur. Other S-1-related adverse events were limited to grade 1-2. Six patients (13%) discontinued S-1 due to either known fluoropyrimidine-related or bevacizumab-related toxicities. Switch to S-1 did not appear to compromise treatment efficacy.

 

Conclusion

S-1 is a valid alternative to capecitabine in case HFS or cardiotoxicity occurs.

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Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer

21 februari 2022

Regular physical activity (PA) is associated with improved overall survival (OS) in stage I–III colorectal cancer (CRC) patients. This association is less defined in patients with metastatic CRC (mCRC). We therefore conducted a study in mCRC patients participating in the Prospective Dutch Colorectal Cancer cohort. PA was assessed with the validated SQUASH questionnaire, filled-in within a maximum of 60 days after diagnosis of mCRC. PA was quantified by calculating Metabolic Equivalent Task (MET) hours per week. American College of Sports and Medicine (ACSM) PA guideline adherence, tertiles of moderate to vigorous PA (MVPA), and sport and leisure time MVPA (MVPA-SL) were assessed as well. Vital status was obtained from the municipal population registry. Cox proportional-hazards models were used to study the association between PA determinants and all-cause mortality adjusted for prognostic patient and treatment-related factors. In total, 293 mCRC patients (mean age 62.9 ± 10.6 years, 67% male) were included in the analysis. Compared to low levels, moderate and high levels of MET-hours were significantly associated with longer OS (fully adjusted hazard ratios: 0.491, (95% CI 0.299–0.807, p-value=0.005) and 0.485 (95% CI 0.303–0.778, p-value=0.003), respectively), as were high levels of MVPA (0.476 (95% CI 0.278–0.816, p-value=0.007)) and MVPA-SL (0.389 (95% CI 0.224–0.677, p-value<0.001)), and adherence to ACSM PA guidelines compared to non-adherence (0.629 (95% CI 0.412–0.961, p-value=0.032)). The present study provides evidence that higher PA levels at diagnosis of mCRC are associated with longer OS.

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Work Ability in Patients With Stage I-IV Colon Cancer: Results of the Dutch Prospective Colorectal Cancer Cohort.

21 oktober 2021

Background: Colon cancer affects a patient's ability to work. Many colon cancer patients are employed at the time of diagnosis.

Objective: We evaluated work ability during the first two years after colon cancer diagnosis.

Design: This study is a national prospective study, the Prospective Dutch ColoRectal Cancer cohort, including clinical data and patient reported outcomes.

Settings: Data were collected in 59 medical centers in the Netherlands.

Patients: Patients <67 years, with stage I-IV colon cancer, who completed work ability index questionnaires, were selected.

Main outcome measures: Work ability was assessed at baseline, 3, 6, 12, 18, and 24 months. The work ability index (ranging from 0-49) was evaluated using linear mixed models. Outcomes were matched to population controls without cancer.

Results: Of 390 patients, 84% had paid employment. Work ability of stage I-IV patients was significantly lower at time of diagnosis compared to matched population controls (31±8.2 and 41±5.6, respectively). Patients with stage I-III disease receiving surgery only regained work ability index scores comparable to matched population controls at 18 months. Patients receiving adjuvant systemic treatment initially demonstrated a decrease in work ability with improvements from 6 months onwards and normalization at 24 months. Stage IV patients did not demonstrate improvements in work ability outcomes over time. Work ability scores were negatively influenced by the administration of systemic treatment and ≥1 comorbidities.

Limitations: Only patients with patient reported outcomes and work at baseline were included in this analysis. Also, questionnaire response rates decreased over time.

Conclusion: Work ability in colon cancer patients is decreased for a prolonged time. Recovery depends on disease stage, type of treatment and comorbidity. Patients with stage I-III disease treated with curative surgery alone are first to regain work ability, followed by patients who receive adjuvant chemotherapy. Stage IV disease patients do not regain work ability. See Video Abstract at http://links.lww.com/DCR/B759.

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Trajectories of health-related quality of life and psychological distress in patients with colorectal cancer: A population-based study

29 augustus 2021

Background: The aim of this nationwide cohort study was to examine the course of symptoms and trajectories of health-related quality of life (HR-QoL) and psychological distress during follow-up and to identify vulnerable patients.
Methods: Patients with pathological stage IeIII colorectal cancer (CRC) between 2013 and 2018 were included. Baseline characteristics were collected from the Netherlands Cancer Registry, and patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30/CR29, Hospital Anxiety and Depression Scale and low anterior resection syndrome (LARS) questionnaires at the baseline and subsequently at 3, 6, 12, 18 and 24 months. Latent class growth and multinomial logistic regression analyses were performed to outline 24-month trajectories in HR-QoL and distress and to identify predictive factors.
Results: : A total of 1535 patients with colon cancer or rectal cancer were included. Trajectory analysis of HR-QoL identified three patient classes: high HR-QoL (62.7%), improving HRQoL (29.0%) and low HR-QoL (8.3%). The following patient groups were identified with having low distress (64.0%), moderate distress (26.9%) and high distress (9.1%). Around 13% of the total cohort had either persistent low HR-QoL or high psychological distress throughout follow-up. Patients belonging to this vulnerable group were significantly more likely to befemale, to be younger aged, to have lower education, to have disease stage II-III or to have major LARS.
Conclusions: Although most patients treated for stage I-III CRC fared well, a small but significant proportion of around 13% did not recover during follow-up and reported low HRQoL and/or high psychological distress levels throughout. This study’s findings should be
taken into account when organising and selecting patients for tailored follow-up.

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Transanal total mesorectal excision and low anterior resection syndrome

1 augustus 2021

Background

Bowel dysfunction after rectal cancer surgery is common, with some experiencing low anterior resection syndrome (LARS) is common after rectal cancer surgery. This study examined if transanal total mesorectal excision (TaTME) has a similar risk of LARS and altered quality of life (QoL) as patients who undergo low anterior resection (LAR).

Methods

Patients who underwent TaTME or traditionally approached total mesorectal excision in a prospective colorectal cancer cohort study (2014–2019) were propensity score matched in a 1 : 1 ratio. LARS and QoL scores were assessed before and after surgery with a primary endpoint of major LARS at 12 months analysed for possible association between factors by logistic regression.

Results

Of 61 TaTME and 317 LAR patients eligible, 55 from each group were propensity score matched. Higher LARS scores (30.6 versus 25.4, P = 0.010) and more major LARS (65 versus 42 per cent, P = 0.013; OR 2.64, 95 per cent c.i. 1.22 to 5.71) were reported after TaTME. Additionally, QoL score differences (body image, bowel frequency, and embarrassment) were worse in the TaTME group.

Conclusions

TaTME may be associated with more severe bowel dysfunction than traditional approaches to rectal cancer.

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Colorectal Cancer Care and Patients' Perceptions Before and During COVID-19: Implications for Subsequent SARS-CoV-2 Infection Waves

13 mei 2021

Background: Changes in colorectal cancer (CRC) care planning because of the coronavirus disease 2019 (COVID-19) pandemic and associated health-related quality of life (HRQoL) and well-being of patients with CRC are unknown. We report changes in CRC care and patient-reported outcomes including HRQoL, distress, and loneliness during the first wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: In April 2020, 4984 patients included in the nationwide Prospective Dutch Colorectal Cancer cohort were invited to complete a COVID-19-specific questionnaire, together with the validated European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), De Jong Gierveld, and Hospital Anxiety and Depression Scale. Clinical data were obtained from the Netherlands Cancer Registry. Scores were compared with the year prior to COVID-19 and with an age- and sex-matched control population during COVID-19.

Results: In total, 3247 (65.1%) patients responded between April and June 2020. Of the patients, 17% had canceled, postponed, or changed hospital visits to a telephone or video consult, and 5.3% had adjusted, postponed, or canceled treatment. Compared with controls, patients reported worse HRQoL but comparable distress and less social loneliness (patients = 21.2%; controls = 32.9%). Compared with pre-COVID-19, clinically meaningful deterioration of HRQoL was more prevalent in patients with changes in cancer care planning than in patients without changes. Prior to undergoing or currently undergoing treatment and infection worries were associated with lower HRQoL.

Conclusions: CRC patients reported equal anxiety and depression but worse HRQoL than the control population. Changes in care planning were associated with deterioration of HRQoL and increased anxiety. In case of 1 or more risk factors, health-care specialists should discuss (mental) health status and possible support during future SARS-CoV-2 infection waves or comparable pandemics.

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Longitudinal effects of adjuvant chemotherapy and related neuropathy on health utility in stage II and III colon cancer patients: A prospective cohort study

6 april 2021

Patient's quality of life should be included in clinical decision making regarding the administration of adjuvant chemotherapy (ACT) in stage II/III colon cancer. Therefore, quality of life, summarized as health utility (HU), was evaluated for patients treated with and without ACT. Furthermore, the role of chemotherapy–induced peripheral neuropathy (CIPN) on HU was evaluated. Patients diagnosed with stage II/III colon cancer between 2011 and 2019 and participating in the Prospective Dutch ColoRectal Cancer cohort were included (n = 914). HU scores were assessed with the EQ‐5D‐5L at baseline, 3, 6, 12, 18, and 24 months. Patients treated with ACT received mainly capecitabine and oxaliplatin (57%) or capecitabine monotherapy (40%) (average duration: 3.5 months). HU 3 to 18 months after diagnosis (potential ACT period + 12 months follow‐up) was compared between patients treated with and without ACT using a mixed model adjusted for age, sex and education level. Subsequently, the CIPN sensory, motor and autonomy scales, measured using the EORTC QLQ‐CIPN20, were independently included in the model to evaluate the impact of neuropathy. Using a mixed model, a significant difference of −0.039 (95% confidence interval: −0.062; −0.015) in HU was found between patients treated with and without ACT. Including the CIPN sensory, motor and autonomy scales decreased the difference with 0.019, 0.015 and 0.02, respectively. HU 3 to 18 months after diagnosis is significantly lower in patients treated with ACT vs without ACT. This difference is on the boundary of clinical relevance and appears to be partly related to the sensory and motor neuropathy‐related side effects of ACT.

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The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real‑world data facilitating research and clinical care

18 februari 2021

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate
treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort,
linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research
collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on
cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and
demographic characteristics of PLCRC participants were compared with the general Dutch CRC
population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between
PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability
to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation
independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016
and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744
patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to
2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability
to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in
the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the
Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to
represent the Dutch CRC population and will ultimately meet the current demand for high-quality
RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s
representativeness and its contribution to a learning healthcare system.

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